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    Pharmacy and Pharmaceutical Facilities Standards

    National Health Regulatory Authority (NHRA)

    Kingdom of Bahrain

    May 2017 Version 1.1

    Chief of Pharmaceutical Product Regulation:

    Dr. / Roaya Al Abbasi Date:

    NHRA CEO Approval:

    Dr. / Mariam Al Jalahma Date:

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    Document Control

    Version Date Author(s) Comments

    1.0 6/9/15 Pharmaceutical Products Regulation Final

    1.1 09/05/17 Pharmaceutical Products Regulation Final

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    Table of contents

    Item Page

    Introduction 4

    The Licensing Standards Structure 5

    Element One Governance, Management and Leadership 6

    Introduction 6

    Element 1: Governance, Management and Leadership - Minimum Criteria 7

    Element Two - Human Resources 11

    Introduction. 11

    Element 2 - Human Resources Standards - Minimum Criteria 12

    Element 3 - Patient and Family Rights 15

    Element 4 - Quality Management and Safety 18

    Introduction 18

    Element 4 Quality Management and Patient Safety - Minimum Criteria 19

    Element 5 - Management of Information and Pharmacy Records 21

    Introduction - Management of Information 21

    Element 5 Management of Information- minimum standards 22

    Element 6 Pharmacy Premises and Equipment 25

    Introduction 25

    Element 6 Pharmacy Premises Minimum Criteria 26

    Element 7 Medication Storage and Stock 29

    Introduction 29

    Element 7 Medication Storage and Stock - Minimum Criteria Standards 30

    Element 8 Warehouse Procurement and Storage 33

    Introduction 33

    Element 8 Warehouse Procurement and Storage - Minimum Criteria Standards 34

    Element 9 Warehouse Transport 37

    Introduction 37

    Element 9 Warehouse Transport - Minimum Criteria Standards 38

    Glossary 39

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    Introduction

    Objectives of Licensing Licensing is a statutory mechanism in the Kingdom of Bahrain which grants permission to health care

    organizations and/or facilities to operate and deliver health care services. A fundamental role of the

    NHRA is to ensure that health care organizations / facilities meet minimum standards to protect public

    health and patient safety and ensure health care services are of a high quality.

    The NHRA grants Health Care facilities a license on an annual basis. This time limited approach requires

    that the facility not only complies with the minimum standards to operate at the outset, but also

    maintains the standards over a sustained period of time to ensure re-licensure is achieved.

    License Inspection Surveys Each inspection survey is carried out using an open and transparent process whilst applying the

    standards within the facility.

    The inspectors will work in a facilitative manner and will discuss and consider specific areas of

    individual elements of the standards throughout the onsite inspection process.

    Standard Development The NHRA licensing standards have been developed using a consensus process. During the

    development the standards went through reviews by various stakeholders, recommendations for

    change were reviewed, considered and applied where appropriate. The standards have been piloted

    across a number of Pharmacy facilities already operating throughout the Kingdom to ensure

    applicability before being approved by the NHRA Board.

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    The Licensing Standards Structure The NHRA Pharmacy/Pharmaceutical Facilities Licensing Standards are assembled around key services

    and functions

    Core Elements (applicable to all Pharmacy Facilities)

    All Pharmacy facilities are assessed against all core elements of the standard

    Each element has an introduction which provides an explanation about the relevance and contribution

    to safety and high quality patient care. Each element has a statement and when required sub-standard

    elements are identified to clarify further requirements. Each element has identified Evidence of

    Compliance (EoC).

    1. Governance, Management and Leadership

    2. Human Resources

    3. Patient and Family Rights

    4. Quality and Safety

    5. Management of Information and Pharmacy Records

    6. Pharmacy Premises and Equipment

    7. Medication Storage and Stock

    Support Element

    8. Warehouse Procurement

    9. Distribution and Storage

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    Element One Governance, Management and Leadership

    Introduction

    For any Pharmacy, quality and patient safety depend on effective leadership and good organization.

    It is important for all pharmacy facilities to have a clearly stated objectives and a mission. It is the

    responsibility of the leadership of the facility to develop the objectives and mission and provide

    adequate resources to fulfill these.

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    Element 1: Governance, Management and Leadership Minimum Criteria

    Governance elements 1.1 to 1.3 apply to pharmacies or chain of pharmacies that have a governing

    body in place:

    1.1. The governing body responsibilities are defined in written documents such as bylaws, policies

    and procedures and reflect the legal responsibilities and accountability it has to the patients

    and public.

    EoC: Governance responsibilities and accountabilities are described in documents. This

    should include responsibility for the quality of care provided and patients safety.

    1.2. The governing body fosters communication and coordination between the pharmacy facilities

    governance function and management within the pharmacy.

    EoC: There is evidence of communication and coordination between the pharmacy

    governance function and management. The governance body approves the mission

    statement, scope of services, strategic and management plans implemented through the

    management and leadership function.

    1.3. The governing body performs periodic evaluation on both its own effectiveness and that of the

    leadership and management team, including review of plans, budgets, policies and procedures.

    EoC: There is evidence of periodic evaluation of the governing body effectiveness and that of

    the management and leadership function within the facility which includes plans, budget,

    policies and procedures.

    1.4. The pharmacy leadership and management ensure that it complies with the laws and

    Regulations in the Kingdom of Bahrain.

    EoC: The pharmacy has a current NHRA License and adheres to the current Kingdom of

    Bahrain laws.

    1.5. The management structure is defined with a clear, current organizational and accountability

    chart identifying name/s and line/s of authority and responsibility of those leading, including

    the governing board /person(s) where appropriate.

    EoC: The governing structure is defined, updated, and circulated throughout the pharmacy: It

    shows the names and titles of those responsible for management and leadership, clear lines

    of authority and accountability.

    1.6. The pharmacy facility should have a clear mission statement which is regularly reviewed and is

    communicated to all staff, patients and visitors.

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    EoC: There is a written mission statement publicly posted within the pharmacy and staffs are

    aware of the mission statement.

    1.7. The pharmacy should have a documented scope of services and practices provided.

    EoC: The pharmacy has an approved and documented scope of services and practices

    provided including the dispensing prescribed drugs, controlled drugs, OTC drugs, Advice and

    Education, counseling, provision of health foods services etc.

    1.8. The pharmacy should have a strategy for providing the identified scope of services/practices

    which includes the provision of adequate resources (manpower, consumables, and capital

    assets).

    EoC: Adequate resources are available for the pharmacy to provide the approved scope of

    services, including adequate manpower, adequate consumables, adequate equipment and

    adequate contracted services where required.

    1.9. A full-time person should be assigned to manage the pharmacy in accordance with applicable

    laws and regulations. They should have a clear written job description covering all aspects of

    their role.

    EoC: An appropriately qualified person is appointed and in post as the person who is held

    accountable for overall pharmacy management and there is evidence of his/her performance

    being managed.

    1.10. The pharmacy fosters open and transparent communication and coordination between its

    management and leaders and the staff.

    EoC: There is evidence of communication between management and staff through newsletters,

    meetings, training and education, notice boards, staff initiatives etc.

    1.11. The pharmacy promotes a top down and bottom up approach to performance improvement,

    patient safety, and a risk management program by collating, regularly reviewing and acting

    upon reports and trends.

    EoC: There are systems in place for collating performance improvement, patients safety and

    risk management statistics and information. There is evidence that this information is

    regular reported and reviewed including:

    Performance improvement activity

    Patient safety initiatives

    Risk management activities

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